1 Year Temporary Contract Medical Operations Regulatory Junior Analyst

1. For AbbVie sponsored clinical studies to support the Medical Operations Regulatory Manager in preparation negotiation and execution of Clinical Studies Agreements and in the relevant  interaction with AbbVie Departments and external interaction with Administration Offices (AOs) at Public and Private Institutions.
    
2. For AbbVie sponsored clinical studies to provide field support to the study Team for clinical   studies submission/updates and follow-up such as:

• optimizing liaison with clinical sites ECs/ AOs
• retrieving comments/questions from ECs/AOs in a timely manner and ensuring AbbVie answers are delivered to the right contact

1. For Investigators Initiated Studies to support Med Ops Regulatory Team in relevant IIS activities and for regularly updating the IIS management systems.
    
2. For Compassionate Uses (PAA programs) to support Med Ops Regulatory Team in managing HCP requests and patients resupplies of drug.
    
3. To ensure archiving of essential documents for all activities above.

Qualifications :

• Italian equivalent to Laurea Magistrale in medical/science/legal related topics or equivalent degree .
• Ability to work efficiently in a matrix context
• Fair Knowledge of English language written and oral .( Minimum level Common European Framework: B1)

Preferred:

1. Previous professional experience in compassionate uses
2. At least 6 month in previous experience in regulatory and ethical aspects pertaining to clinical research
3. Specialty degree or PhD

Additional Information :

Your total reward package at AbbVie will be made up of multiple components including compensation well-being and benefits.

Full details of our comprehensive package will be shared during the recruitment process. 

The national collective bargaining agreement applicable to this position is B011 CCNL Chemical-Pharmaceuticals Industry.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time